510(k) · Cleared
ClearedSkintemp, Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocore · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Feb 23, 1993 after a 131-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- Feb 23, 1993
- Review
- 131 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK925545 Skintemp, ModificationBiocore · 1993
- Descendant · cites it directly · 3 of its ownK122325 Skintemp IIHuman Biosciences, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK100927 SurgiaidMaxigen Biotech, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK213092 Cellusheet, CellufilHuman Biosciences, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK253974 Roosin Collagen DressingRoosin Medical Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK232758 Comatryx OTCStrukmyer Medical, LLC · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122325Skintemp IIHuman Biosciences, Inc. · 2012 · cites it directly3descendants
- K100927SurgiaidMaxigen Biotech, Inc. · 2011 · cites it directly2descendants
- K213092Cellusheet, CellufilHuman Biosciences, Inc. · 2021 · cites it directly1descendant
- K253974Roosin Collagen DressingRoosin Medical Co., Ltd. · 2026 · 2 generations on0descendants
- K232758Comatryx OTCStrukmyer Medical, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925545 | Skintemp, Modification | Biocore | 1993 | — |
| +1 | K122325 | Skintemp II | Human Biosciences, Inc. | 2012 | — |
| +1 | K100927 | Surgiaid | Maxigen Biotech, Inc. | 2011 | — |
| +1 | K213092 | Cellusheet, Cellufil | Human Biosciences, Inc. | 2021 | — |
| +2 | K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | 2026 | — |
| +2 | K232758 | Comatryx OTC | Strukmyer Medical, LLC | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122325 (Human Biosciences, Inc., 2012) has gone furthest, with 3 descendants of its own.
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
https://510kreport.com/device/K925545 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925545: Skintemp, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925545
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026